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BACKGROUND: Andexanet Alfa (AA) is the only FDA approved reversal agent for apixaban and rivaroxaban (DOAC). There are no studies comparing its efficacy with 4-Factor Prothrombin Complex Concentrate (PCC). This study aimed to compare PCC to AA for DOAC reversal, hypothesizing non-inferiority of PCC. METHODS: We performed a retrospective, non-inferiority multicenter study of adult patients admitted from July 1, 2018 to December 31, 2019 who had taken a DOAC within 12 hours of injury, were transfused red blood cells (RBCs) or had traumatic brain injury, and received AA or PCC. Primary outcome was PRBC unit transfusion. Secondary outcome with ICU length of stay. MICE imputation was used to account for missing data and zero-inflated poisson regression was used to account for an excess of zero units of RBC transfused. 2 Units difference in RBC transfusion was selected as non-inferior. RESULTS: Results: From 263 patients at 10 centers, 77 (29%) received PCC and 186 (71%) AA. Patients had similar transfusion rates across reversal treatment groups (23.7% AA vs 19.5% PCC) with median transfusion in both groups of 0 RBC. According to the Poisson component, PCC increases the amount of RBC transfusion by 1.02 times (95% CI: 0.79-1.33) compared to AA after adjusting for other covariates. The averaged amount of RBC transfusion (non-zero group) is 6.13. Multiplying this number by the estimated rate ratio, PCC is estimated to have an increase RBC transfusion by 0.123 (95% CI: 0.53-2.02) units compared to AA. CONCLUSION: PCC appears non-inferior to AA for reversal of DOACs for RBC transfusion in traumatically injured patients. Additional prospective, randomized trials are necessary to compare PCC and AA for the treatment of hemorrhage in injured patients on DOACs. LEVEL OF EVIDENCE: Therapeutic/Care Management, Level III.
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PURPOSE: The incidence of sternal fractures in blunt trauma patients lies between 3 and 7%. The role, timing and indications for surgical management are not well delineated and remain controversial for patients undergoing surgical stabilization of sternum fracture (SSSF). We sought to identify the national rate of SSSF in patients with a sternum fracture hypothesizing patients undergoing SSSF will have a decreased rate of mortality and complications. METHODS: The Trauma Quality Improvement Program (2015-2016) was queried for patients with sternum fracture. Propensity scores were calculated to match patients undergoing SSSF to patients managed non-operatively in a 1:2 ratio using demographic data. RESULTS: From 9460 patients with a sternum fracture, 114 (1.2%) underwent SSSF. After propensity-matching, 112 SSSF patients were compared to 224 patients undergoing non-operative management (NOM). There were no differences in matched characteristics (all p > 0.05). Compared to patients undergoing NOM, patients undergoing SSSF had an increased median length of stay (LOS) (16 vs. 7 days, p < 0.001), ICU LOS (9.5 vs. 5.5 days, p = 0.016) and ventilator days (8 vs. 5, p = 0.035). The SSSF group had a similar rate of ARDS (2.7% vs. 2.2%, p = 0.80), pneumonia (1.8% vs. 0.9%, p = 0.48) and unplanned intubation (8.9% vs. 5.8%, p = 0.29) but a lower mortality rate (2.7% vs. 11.2%, p = 0.008). CONCLUSION: Just over 1% of patients with sternum fracture underwent SSSF in a national analysis. Patients undergoing SSSF had an increased LOS and similar rate of all measured pulmonary complications, however a lower mortality rate compared to patients managed non-operatively.
Assuntos
Fraturas Ósseas , Traumatismos Torácicos , Fixação Interna de Fraturas , Fraturas Ósseas/cirurgia , Humanos , Tempo de Internação , Estudos Retrospectivos , Esterno/cirurgiaRESUMO
BACKGROUND: Small case series have suggested that selective nonoperative management (NOM) of penetrating internal jugular vein (IJV) injuries is safe and feasible in select patients lacking "hard signs" mandating exploration. Therefore, we sought to compare NOM to operative management (OM) of penetrating IJV injury, hypothesizing that both strategies have similar patient outcomes and mortality when patients are appropriately selected. METHODS: The Trauma Quality Improvement Program (2013-2016) was queried for patients with penetrating IJV injury with an abbreviated injury scale score of the neck ≥3. Demographics and patient outcomes were compared between patients undergoing NOM and patients undergoing OM, followed by a multivariable logistic regression model to analyze the risk of mortality. RESULTS: A penetrating IJV injury was identified in 188 (0.01%) patients meeting inclusion criteria, and OM was performed in 124 (66.0%) patients, whereas 64 (34.0%) patients underwent NOM. Although the OM group had a higher rate of pneumothorax (8.9% vs. 0.0%, P = 0.01), there was no difference in any other concomitant injuries or demographic data (all P > 0.05). The OM group had a higher rate of ventilator days (3 vs. 2 days, P = 0.01) but no other significant differences in morbidity or mortality (P > 0.05). After controlling for covariates, OM was associated with similar risk of mortality compared with NOM of patients with penetrating IJV injury (odds ratio 1.05, confidence interval 0.23-4.83, P = 0.95). CONCLUSIONS: The NOM of penetrating IJV injuries is associated with similar risk of morbidity and mortality compared with OM, suggesting that NOM may be used in appropriately selected patients. Future research is needed to determine the ideal patients suited for NOM and to identify risk factors and outcomes associated with failure of NOM.